AB0758 Golimumab after discontinuation of non-TNF inhibitors in patients with inflammatory rheumatic diseases: four-year retention rate in the Spanish BIOBADASER registry
Authors: M. Pombo-Suarez, D. Seoane-Mato, F. Diaz-Gonzalez, F. Sánchez-Alonso, L. Cea-Calvo, M. Sánchez-Jareño, V. Jovani, P. Pretel, F. J. Manero Ruiz, I. Castrejon
Journal: Annals of the Rheumatic Diseases (2022)

Background Treatment options for rheumatic diseases have evolved to include mechanisms of action beyond tumor necrosis factor inhibitors (TNFi). While non-TNFi biologics and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDS) have been studied as first-line therapy or after TNFi discontinuation, data on the use of TNFis after discontinuation of these drugs is scarce. Objectives We assessed the probability of retention (persistence or drug survival) of golimumab in patients with rheumatic diseases when used after discontinuation of non-TNFi biologicals or tsDMARDs. Methods Characteristics of all adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (SpA) who had initiated golimumab after discontinuation of non-TNFi biologicals or tsDMARDs in the BIOBADASER database were analyzed. The probability of golimumab retention was assessed with the Kaplan-Meier method, and differences between groups with the log-rank test. Patients were right-censored if they were still treated with golimumab at the last observation for data analysis. We also compared the probability of retention of patients who initiated golimumab after discontinuation of non-TNFi biologicals or tsDMARDs with that of patients who initiated it after discontinuation of TNFis. Results A total of 125 patients (85 [68%] women) with RA (n=72), axSpA (n=23), or PsA (n=30) had initiated golimumab after discontinuation of non-TNFi biologicals or tsDMARD. Golimumab had been initiated as second line of therapy (i.e., after discontinuation of a first non-TNFi biological or tsDMARD) in 26 patients (21%), as third in 29 (23%) and as fourth/subsequent line of therapy in 70 patients (56%). Upon golimumab initiation, the median disease duration was 10.0 years. The most common previously discontinued therapies were secukinumab (n=34) and abatacept (n=23). The retention rates of golimumab were 61% (95% confidence interval [CI]: 51-69) at year 1 (number at risk: 66), 46% (95% CI: 36-55) at year 2 (number at risk: 39), 40% (95% CI: 30-50) at year 3 (number at risk: 23) and 33% (95% CI: 23-44) at year 4 (number at risk: 13). There were no differences in retention rates over 4 years when golimumab was used as the second, third, or fourth/subsequent line of therapy (p=0.462). Retention rate was lower in RA patients (26% at year 3) than in axial SpA (68%) or PsA (49%) (p=0.002) (Figure 1). As second line therapy, the 3-year retention rate of golimumab was slightly lower when it was initiated after non-TNFi biologicals/tsDMARD than when the previously discontinued therapy was a TNFi (32% vs 55%, p=0.119), but the figures were similar when it was initiated as third (52% after non-TNFi biologicals/tsDMARD vs 50% after TNFi, p=0.838) or as fourth/subsequent line of therapy (37% vs 44% respectively, p=0.554). Conclusion We present, for the first time, 4-year retention rates for golimumab in patients who discontinued non-TNFi biologicals or tsDMARDs, most of them in third and fourth/subsequent line of therapy. In this difficult-to-treat rheumatic population, overall golimumab retention rates were favorable through 4 years of treatment, with higher rates in SpA and PsA compared to RA patients. Figure 1. Acknowledgements BIOBADASER is funded by the Spanish Society of Rheumatology, the Spanish Agency of Medicines and by different pharmaceutical companies. This study was funded by MSD, Spain. Disclosure of Interests Manuel Pombo-Suarez: None declared, Daniel Seoane-Mato: None declared, Federico Diaz-Gonzalez: None declared, Fernando Sánchez-Alonso: None declared, Luis Cea-Calvo Employee of: MSD Spain, Marta Sánchez-Jareño Employee of: MSD Spain, Vega Jovani: None declared, Paula Pretel: None declared, Francisco Javier Manero Ruiz: None declared, Isabel Castrejon: None declared